Roche said on Monday that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq (atezolizumab) for metastatic urothelial carcinoma (mUC).
Urothelial carcinoma accounts for 90 percent of all bladder cancers and can also be found in the renal pelvis, ureter and urethra.
This is another step for the Swiss-based drugmaker in making Tecentriq available for more types of cancer patients.
“In May 2016, Tecentriq became the first treatment approved by the FDA for people with previously treated advanced bladder cancer in more than 30 years,” said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development.
Roche will wait for the end of April 2017, when the FDA will make a decision on approval.
A Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the safety and effectiveness of the treatment, prevention or diagnosis of a serious disease.
Tecentriq is currently approved by the FDA to treat people with locally advanced or mUC-